FDA 510(k)

Airborne光疗灯

K号: K160238 · 2016-06-14

决定日期2016-06-14

产品代码LBI

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

Airborne Phototherapy Light is the device name listed in this FDA 510(k) record. The listed applicant is International Biomedical. It received FDA 510(k) clearance on 2016-06-14 under 510(k) number K160238. The device is classified under product code LBI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Airborne Phototherapy Light?

Airborne Phototherapy Light is a medical device that received FDA 510(k) clearance on 2016-06-14. The listed applicant is International Biomedical. The 510(k) number is K160238.

When did Airborne Phototherapy Light receive FDA 510(k) clearance?

Airborne Phototherapy Light received FDA 510(k) clearance on 2016-06-14, under 510(k) number K160238.

Who is the listed applicant for Airborne Phototherapy Light?

The FDA 510(k) record lists International Biomedical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Airborne Phototherapy Light?

The FDA product code for Airborne Phototherapy Light is LBI.

列明International Biomedical为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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